responsibilities of test facility management & · pdf fileresponsibilities of test...

OECD Event, Villa Tuscolana, Frascati (Roma), Italy , April 10 OECD Event, Villa Tuscolana, Frascati (Roma), Italy , April 10 –– 11,11, 2008 2008

Responsibilities of Test Facility Responsibilities of Test Facility Management & SponsorManagement & Sponsor

Rik HendriksRik HendriksWerner CoussementWerner Coussement

J&J R&DQA, Beerse, BelgiumJ&J R&DQA, Beerse, [email protected]@prdbe.jnj.com

J&J GPCD, Beerse, BelgiumJ&J GPCD, Beerse, [email protected]@prdbe.jnj.com


Responsibilities of management & sponsor

• Responsible people• Quality Assurance• Test facility, supplies, test item, computerized systems• SOP’s• Performance of a study

OECD 1: OECD Principles of Good Laboratory PracticeOECD 11: The Role and Responsibilities of the Sponsor OECD 13: Organisation and Management of Multi-Site Studies OECD 15: Archives


Management

• Definition: Test Facility Management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to GLP

• What does this mean?

– Identification of management

– Job descriptions

– SOP on the organisation of the test facility

– Sufficient number of qualified personnel, Master Schedule, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study


Personnel

• Record of the qualifications, training, experience and job description

• Personnel clearly understand their functions


– CV, Basic Training Plan

– SOPs and SOP training

– Development plan and ongoing training


Study Director

• Designate a Study Director for each study• Replacement of a Study Director

• Study Director workload


– Study request form, kept in raw data

– Development Plan & ongoing training

– Described in SOPs (incl. replacement) and documented in raw data


Principal Investigator

• Multi-site study: designation of a Principal Investigator• Replacement done according to established procedures, and

documented


– Same principles as for Study Director request form, basic and on-going training, documented replacement


Quality Assurance

• Quality Assurance Program


– Independent reporting structure

– Approved document appointing QA and listing responsibilities

– Access to Master Schedule

– QA audits reported to management

• Inspection reports (study specific, system, CRO)

• Overview reporting of observations and trending with trend analysis

– Open communication

– Proactive handling, Innovative solutions, Risk Management


Test facility supplies

• Test facility supplies meet requirements appropriate to their use in a study


– Reagents, materials, animals, food, equipment, …

• as much as possible from ISO certified companies

• vendor audits performed by QA

• equipment: validated, calibrated and quality controlled


Test and reference item

• Test and reference items are appropriately characterized


– Certificate of analysis available before the start of the study

• identity with batch No.

• purity

• stability

• storage conditions

• …


Computerized systems

• Computerized systems are suitable for their intended purpose and validated, operated and maintained in accordance with GLP


– IT departement with internal preclinical IT team

– Validation methodology described in policy and SOPs

– Master Validation Plan

– Validation file for all computerised systems and defined change control

– QA audits


SOPs

• Appropriate and technically valid SOPs established and followed

• Approve original and revised SOPs

• Maintain historical file of SOPs


– SOP management System

– Procedure on how to manage SOPs

– Defined responsibilities for SOP owners


Performance of a study

• Documented approval of study plan

• Multi-site study: clear lines of communication between SD, PI, QA and study personnel


– Study plan is signed by SD, management signs as sponsor rep (described in SOP)

– Procedure on study plan distribution and documented evidence

– Multi-site: Described in procedures and study plan

– Multi-site: Documented communication


Archives

• Individual identified as responsible for management of the archive

• Records and materials should be archived

• Out of business: the archive should be transferred


– Archivist appointed, responsibilities described in job description

– Paper, material and electronic archiving described in SOPs

– Controlled access

– Described in study plan and reflected in the report

– Discussed and audited during CRO evaluation

– Described in SOP (checked during CRO evaluation)


Sponsor responsibilities

• Definition: Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study

• Ensure that the test facility is able to conduct the study in compliance with GLP and that it is aware that the study is to be performed under GLP

• What does this mean?– Before the start of a study• Preselection visits and Audits by QA/Sponsor scientists

– Ongoing follow-up• QA audits and Study monitor visits

– GLP requirement described in contract & study plan



• Provision of chemical safety information• Characterization of the test item, carried out either by the

contracted test facility or by the sponsor

• Submission of data to regulatory authorities:Study Director = scientific validity of a studySponsor = make the decision, based on the outcome of the study


– Safety information is provided before the start of the study

– Certificate of analysis is provided and is part of the final report

– Sponsor’s decision to submit final report to HA



•Materials and records are retained and maintained under conditions that ensure their integrity and continued accessIf records and materials transferred into the sponsors possession = storage in GLP archives

•What does this mean?

– Study plan specifies how long data are being stored

– Archiving can be done internally or externally (part of CRO evaluation)


Common Responsibility of Health Authority

and Pharma Industry

Opportunity in front of us to step uptogether to come up with one global set of GLP Principles which in turn can lead to one global submission file.

It is firmly hoped that Health Authorities and Industry, hand in hand, can actually optimize their interaction to the overall benefit of human health.


Thanks to my Johnson & Johnson colleagues from Global R&DQA and Global Pre-clinical Development

with a special thank to

Hilde Van den Eynde, Betty DeLise,

Jerry Snoeks and Kirk Huber

responsibilities of test facility management & · pdf fileresponsibilities of test...

Documents